Cardiac SurgeryNCT02852889
Internal Jugular Vein Distensibility to Predict Fluid Responsiveness in Patients After Cardiac Surgery
An observational study of Cardiac Surgery, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
The purpose of the study was to verify the efficacy of using internal jugular vein (IJV) size and distensibility as an index of fluid responsiveness in mechanically ventilated patients after cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Jul 2016to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients after cardiac surgery
Who may be able to join
- hypotension
- oliguria
- high lactate level
Who cannot join
- cardiac arrhythmia
- clinically relevant tricuspid or mitral regurgitation, clinically relevant right heart failure
- thrombosis in any large upper body veins
- bilaterally inserted venous catheters
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Zhe Luo, +86-21-64041990 ext. 3659
About this study
The purpose of the study was to verify the efficacy of using internal jugular vein (IJV) size and distensibility as an index of fluid responsiveness in mechanically ventilated patients after cardiac surgery.
- Conditions
- Cardiac Surgery
- Keywords
- internal jugular vein distensibility,haemodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| fluid responders | Patients whose stroke volume index increase by >10% in response to a 500-ml fluid bolus was defined as fluid responders. | |
| fluid non-responders | Patients whose stroke volume index increase by <10% in response to a 500-ml fluid bolus was defined as fluid non-responders. |
What is being measured
The primary outcome is the main question the study is designed to answer.
fluid responsiveness （mean artery pressure、cardiac output、stroke volume variation、internal jugular vein distensibility）
CO increased more than 10% was defined as fluid responsiveness
Measured: after fluid challenge (30min)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guo-wei Tu, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02852889
- Sponsor's protocol ID
- B2016-077
- Status last verified
- Aug 2016
- First submitted
- 29 Jul 2016
- Last updated
- 4 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internal Jugular Vein Distensibility to Predict Fluid Responsiveness in Patients After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02852889
- Acronym / sponsor ID
- B2016-077
- Conditions
- Cardiac Surgery
- Keywords
- internal jugular vein distensibility,haemodynamics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Dec 2016 (estimated)
- First posted
- 2 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study was to verify the efficacy of using internal jugular vein (IJV) size and distensibility as an index of fluid responsiveness in mechanically ventilated patients after cardiac surgery.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fluid responders | – | –Patients whose stroke volume index increase by >10% in response to a 500-ml fluid bolus was defined as fluid responders. |
| fluid non-responders | – | –Patients whose stroke volume index increase by <10% in response to a 500-ml fluid bolus was defined as fluid non-responders. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients after cardiac surgery
Key inclusion criteria (3 listed)
- hypotension
- oliguria
- high lactate level
Key exclusion criteria (4 listed)
- cardiac arrhythmia
- clinically relevant tricuspid or mitral regurgitation, clinically relevant right heart failure
- thrombosis in any large upper body veins
- bilaterally inserted venous catheters
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
fluid responsiveness （mean artery pressure、cardiac output、stroke volume variation、internal jugular vein distensibility）
Time frame: after fluid challenge (30min)
CO increased more than 10% was defined as fluid responsiveness
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guo-wei Tu, PhD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Surgery, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhe Luo, PhD (021-64041990 ext. 3659, luo.zhe@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fluid responsiveness （mean artery pressure、cardiac output、stroke volume variation、internal jugular vein distensibility） (time frame: after fluid challenge (30min)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2016.